Validation of the Dayzz Digital Sleep Training App in Insomnia and Sleep Apnea

NCT ID: NCT03955120

Last Updated: 2021-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-29
• Study Completion Date: 2020-12-30

Brief Summary

The prevalence of sleep disorders has achieved epidemic proportions in Western countries. Despite this, assessment and treatment of sleep disorders remains infrequent, unattainable, and often costly. Dayzz is aware of the need for easily accessible, user-friendly, and affordable treatment strategies for known sleep conditions. This research proposes a randomized controlled outcome study aimed to validate a, digitized, cost-effective mobile app which assesses and manages insomnia and CPAP adherence in persons with sleep apnea. The app's sleep training protocols recommend life-style and behavioral changes and tracks these changes with the aim of improving sleep and well-being. In this study, the dayzz app digital treatment protocol will be compared to the standard treatment for these sleep conditions by a sleep professional.

Conditions

Insomnia; Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sleep Apnea- Dayzz

The intervention group is also provided access to the dayzz app, a personalized digital sleep training program. The sleep training begins a sleep assessment questionnaire and ongoing sleep and activity data collection which is used to tailor an individualized sleep training program including behavioral and cognitive techniques to improve the adherence to CPAP. The dayzz sleep program is composed of three main components, (1) a mobile digital program via the dayzz app, (2) guidance of a sleep trainer, and (3) an ambulatory sleep monitoring device. The intervention group meets a CPAP technician at the sleep clinic, as detailed below in the Sleep Apnea TAU group

Group Type: EXPERIMENTAL

Dayzz mobile sleep training

Intervention Type: BEHAVIORAL

1. The dayzz digital sleep program provides each user with relevant educational materials (depending on their sleep condition), sleep tracking, and sleep or health-related tasks or challenges pertaining to their sleep or sleep difficulties.

2. Each app user is matched with a "sleep trainer" who will communicate with them via a "chat" option within the dayzz app and who will support the participants with any sleep training issues or technical aspects of all app for the duration of the treatment program.

3. Participants receive a wrist-worn device for monitoring sleep and activity patterns, a Fitbit fitness tracker (www.fitbit.com), to be worn for the duration of the study.

Sleep Apnea- Treatment as Usual

The "treatment as usual" \[TAU\] group meets a CPAP technician at the sleep clinic, who provides the participant with a CPAP device and fits the mask. The will also receive a follow-up visit with the same technician for technical support, mask changes or alterations if needed after an initial 7 to 14-day at home CPAP trial.

Group Type: ACTIVE_COMPARATOR

Treatment as usual

Intervention Type: OTHER

Standard medical care for specific sleep condition

Insomnia - Dayzz

The intervention group is provided access to the dayzz app, a personalized digital sleep training program. The sleep training begins a sleep assessment questionnaire and ongoing sleep and activity data collection which is used to tailor an individualized sleep training program including behavioral and cognitive techniques to improve the insomnia concerns, sleep symptoms, and achieve sleep goals. The dayzz sleep program is composed of three main components, (1) a mobile digital program via the dayzz app, (2) guidance of a sleep trainer, and (3) an ambulatory sleep monitoring device.

Group Type: EXPERIMENTAL

Dayzz mobile sleep training

Intervention Type: BEHAVIORAL

1. The dayzz digital sleep program provides each user with relevant educational materials (depending on their sleep condition), sleep tracking, and sleep or health-related tasks or challenges pertaining to their sleep or sleep difficulties.

2. Each app user is matched with a "sleep trainer" who will communicate with them via a "chat" option within the dayzz app and who will support the participants with any sleep training issues or technical aspects of all app for the duration of the treatment program.

3. Participants receive a wrist-worn device for monitoring sleep and activity patterns, a Fitbit fitness tracker (www.fitbit.com), to be worn for the duration of the study.

Insomnia - Treatment as Usual

The "treatment as usual" \[TAU\] group, will receive standard treatment recommendations for their insomnia, including sleep hygiene suggestions, referral for supportive/non-medical treatments \[e.g. relaxation therapies\], and if needed hypnotics or other medications prescribed by the sleep clinic physician.

Group Type: ACTIVE_COMPARATOR

Treatment as usual

Intervention Type: OTHER

Standard medical care for specific sleep condition

Interventions

Dayzz mobile sleep training

1. The dayzz digital sleep program provides each user with relevant educational materials (depending on their sleep condition), sleep tracking, and sleep or health-related tasks or challenges pertaining to their sleep or sleep difficulties.

2. Each app user is matched with a "sleep trainer" who will communicate with them via a "chat" option within the dayzz app and who will support the participants with any sleep training issues or technical aspects of all app for the duration of the treatment program.

3. Participants receive a wrist-worn device for monitoring sleep and activity patterns, a Fitbit fitness tracker (www.fitbit.com), to be worn for the duration of the study.

Intervention Type: BEHAVIORAL

Treatment as usual

Standard medical care for specific sleep condition

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients aged 21-65 years of age referred to the Carmel Hospital sleep clinic and diagnosed by the clinic physician with either Sleep Apnea (referred for CPAP treatment) or Insomnia.

Exclusion Criteria

• Patient age <21 years.
• Patient who is not a member of Clalit Healthcare services.
• Persons with insufficient control of the English language required for adequate use of app.
• Persons with insufficient experience/knowledge and/or use of digital apps/smartphones.
• Persons with serious medical or psychiatric conditions.
• Women who are pregnant or breastfeeding.
• Nighttime shift-workers.
• Persons who are unable to provide consent due to mental incapacity.
• Persons referred for evaluation of sleep by Ministry of Transportation (for licensing purposes).
• Persons with comorbid insomnia and sleep apnea

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Israel Innovation Authority

UNKNOWN

Sponsor Role: collaborator

Dayzz Live Well Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Carmel Hospital

Haifa, , Israel

Countries

Israel

Other Identifiers

Dayzz_002

Identifier Type: -

Identifier Source: org_study_id